Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350383
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-14
Brief Title:
Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Adapting a Low-cost Intimate Partner Violence IPV and Mental Health Response Intervention for Women in Informal Settlements in Kenya
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this feasibility study clinical trial is to test a low-cost combined adapted intimate partner violence IPV and mental health intervention Wings of Hope WINGS Problem Management Plus PM that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya The main aims of the study are to 1 assess the safety feasibility and acceptability of WINGSPM among women experiencing IPV in informal settlements in Kenya 2 to test preliminary efficacy of program mediating outcomes in addition to the distal outcome incidenceseverity of IPV while closely monitoring fidelity or process measures including attendanceretention adherence quality of delivery participant satisfaction safety and quality improvement and adaptation modifications and 3 generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial Women experiencing IPV n260 will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement n130 and Upendo Clinic in Mathare informal settlement n130 Consenting women will be screened for experiences of recent IPV last 3 months Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGSPM intervention n65 or the PM-only intervention controlcomparison arm n65 at each clinic
Detailed Description:
Women experiencing IPV n260 will be recruited from the outpatient walk-in departments at Kianda 42 Clinic in Kibera informal settlement n130 and Upendo Clinic in Mathare informal settlement n130 Consenting patients will be screened for recent experiences of IPV past 3 months by nurses or staff using an adapted version of the World Health Organization WHO IPV Brief Self-screener IPV-BSS and asked several mental health and functioning questions
Informational scripts about the study will be shared and posted at the two clinics and also shared by community health volunteers CHVs with clinic patients during routine household visits Every CHV who is attached to a clinic is responsible for doing routine visits with clinic patients in up to 100 households each month in the informal settlement in which the clinic is located The purpose of these routine household visits is to check-in on patients let households know about new or relevant clinic programs and carry out relevant health-related trainings eg how to treat water during a cholera outbreak or how to practice proper hygiene during COVID The informational script will let patients in the clinics and broader community know that if they are interested in the program they can come to the clinic to be screened for eligibility
EligibilityIPV screens will be collected by trained non-specialist in-take staff in a private in-take room at the Kianda 42 Clinic in Kibera and Upendo in Mathare Screening is anonymous No identifying information will be collected as part of the screen Answers to the screening questions will be recorded on digitally on study tablets Verbal consent for eligibility screens will be collected In-take staff will note on the informed consent document that the participant verbally consented to the screening and sign their own names to attest to participants consent
If women screen positive for IPV in the past three months and meet the rest of the eligibility criteria they will be asked if they are interested in participating in the feasibility trial If they express interest they will be referred to a trained CHV who will take them through the a digital Informed Consent Process for the feasibility trial
Consenting participants will be guided through a baseline assessment by a CHV and then randomized to either the combined WINGSPM n130 65 at Kianda 42 and 65 at Upendo or the psychological-only PM arm n130 65 at Kianda 42 and 65 at Upendo Block randomization with random block sizes will be used to force a balance between study arms with respect to the number of women per arm per clinic
WINGSPM and PM-only sessions will be delivered by trained CHVs at Kianda 42 and Upendo WINGSPM is a safety harm reduction and brief psychological intervention combined and adapted by community members from informal settlements in Kenya IPV survivors health clinic staff and CHVs from two evidence-based interventions Wings of Hope WINGS and Problem Management Plus PM This intervention was designed to be facilitated by non-specialists eg CHVs It involves seven 90-minute weekly sessions focused on exploring types and mechanisms of IPV eg the role of household economics in IPV building motivation to address IPV safety planning and revision enhancing social support to address IPV goal setting and revision identifying IPV-related services and needs linkage and referral to services self-care planning learning and practicing a stress management technique identifying defining and managing problems through goal setting and review increasing engagement in positive activities strengthening social supports and developing plans to stay healthy and well beyond the intervention PM is a brief psychological intervention also designed to be facilitated by non-specialists eg CHVs and focused on problem management and evidence-based behavioral strategies to enhance ones capacity to adaptively manage psychological distress It has been shown to be effective at reducing psychological distress among women who have experienced gender-based violence in informal settlements in Nairobi Kenya PM involves five 90-minute weekly individual sessions focused on learning and practicing a stress management technique identifying defining and managing problems through goal setting and review increasing engagement in positive activities strengthening social supports and developing plans to stay healthy and well beyond the intervention
Intervention outcomes will be assessed at four time points baseline immediately post intervention IPI 3-month and 6-month follow-up
To reduce contamination CHVs will either carry out assessment or facilitate the intervention Some CHVs will deliver PM-only while others will deliver the WINGSPM intervention Project staff will meet regularly with CHVs providing PM only to establish the types of support and counselling they offered to participants and check that there was no contamination of the WINGSPM strategies in the PM-only arm All intervention sessions will be audio-recorded for quality assurance
Informational scripts about the study will be shared and posted at the two clinics and also shared by community health volunteers CHVs with clinic patients during routine household visits Every CHV who is attached to a clinic is responsible for doing routine visits with clinic patients in up to 100 households each month in the informal settlement in which the clinic is located The purpose of these routine household visits is to check-in on patients let households know about new or relevant clinic programs and carry out relevant health-related trainings eg how to treat water during a cholera outbreak or how to practice proper hygiene during COVID The informational script will let patients in the clinics and broader community know that if they are interested in the program they can come to the clinic to be screened for eligibility
EligibilityIPV screens will be collected by trained non-specialist in-take staff in a private in-take room at the Kianda 42 Clinic in Kibera and Upendo in Mathare Screening is anonymous No identifying information will be collected as part of the screen Answers to the screening questions will be recorded on digitally on study tablets Verbal consent for eligibility screens will be collected In-take staff will note on the informed consent document that the participant verbally consented to the screening and sign their own names to attest to participants consent
If women screen positive for IPV in the past three months and meet the rest of the eligibility criteria they will be asked if they are interested in participating in the feasibility trial If they express interest they will be referred to a trained CHV who will take them through the a digital Informed Consent Process for the feasibility trial
Consenting participants will be guided through a baseline assessment by a CHV and then randomized to either the combined WINGSPM n130 65 at Kianda 42 and 65 at Upendo or the psychological-only PM arm n130 65 at Kianda 42 and 65 at Upendo Block randomization with random block sizes will be used to force a balance between study arms with respect to the number of women per arm per clinic
WINGSPM and PM-only sessions will be delivered by trained CHVs at Kianda 42 and Upendo WINGSPM is a safety harm reduction and brief psychological intervention combined and adapted by community members from informal settlements in Kenya IPV survivors health clinic staff and CHVs from two evidence-based interventions Wings of Hope WINGS and Problem Management Plus PM This intervention was designed to be facilitated by non-specialists eg CHVs It involves seven 90-minute weekly sessions focused on exploring types and mechanisms of IPV eg the role of household economics in IPV building motivation to address IPV safety planning and revision enhancing social support to address IPV goal setting and revision identifying IPV-related services and needs linkage and referral to services self-care planning learning and practicing a stress management technique identifying defining and managing problems through goal setting and review increasing engagement in positive activities strengthening social supports and developing plans to stay healthy and well beyond the intervention PM is a brief psychological intervention also designed to be facilitated by non-specialists eg CHVs and focused on problem management and evidence-based behavioral strategies to enhance ones capacity to adaptively manage psychological distress It has been shown to be effective at reducing psychological distress among women who have experienced gender-based violence in informal settlements in Nairobi Kenya PM involves five 90-minute weekly individual sessions focused on learning and practicing a stress management technique identifying defining and managing problems through goal setting and review increasing engagement in positive activities strengthening social supports and developing plans to stay healthy and well beyond the intervention
Intervention outcomes will be assessed at four time points baseline immediately post intervention IPI 3-month and 6-month follow-up
To reduce contamination CHVs will either carry out assessment or facilitate the intervention Some CHVs will deliver PM-only while others will deliver the WINGSPM intervention Project staff will meet regularly with CHVs providing PM only to establish the types of support and counselling they offered to participants and check that there was no contamination of the WINGSPM strategies in the PM-only arm All intervention sessions will be audio-recorded for quality assurance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None